References referred to in the text by a number enclosed by parenthesis are listed at the end of the specification.
The goal of pregnancy management is the delivery of a mature, healthy infant, without encountering complications which can adversely affect the well being of both the mother and the newborn. A significant percentage of pregnancies are affected by various disorders. Among these complications are preterm labor and delivery, intrauterine growth retardation and preeclampsia. These conditions negatively impact the outcome of affected pregnancies, at enormous cost both to the patients as well as to the health system.
Placental Protein 13 (PP13) is a protein which was previously isolated from human placental tissue (U.S. Pat. No. 4,500,451 to Bohn, et al., the contents of which are incorporated herein by reference). The protein was characterized by the following parameters: electrophoretic mobility, isoelectric point, sedimentation coefficient, molecular weight determined by ultracentrifugation, molecular weight determined by SDS-PAGE, extinction coefficient and carbohydrate content. The amino acid composition (residues per 100 residues) was determined but not the amino acid sequence.
PP13 was used to develop an assay for the early stage detection of three specific pregnancy-related disorders: intrauterine growth retardation, preeclampsia and preterm delivery (U.S. Pat. No. 5,198,366 to Silberman). Both a radioimmunoassay (RIA) and an enzyme-linked immunoassay (ELISA) are disclosed using labeled PP13 and anti PP13 antiserum, respectively. No further properties of PP13 are disclosed in the Silberman patent.